The University of Kansas Medical Center
Presentation Abstract
A Randomized Phase III Double-Blind Clinical Trial (S1600) Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes in Progress
Background: This phase III trial compares the impact of consuming Specialized IMmunonutrition (SIM) to oral nutritional support on postoperative complications after radical cystectomy. SIM is fortified with nutrients (L-arginine, omega-3 fatty acids, and dietary nucleotides) that have immediate effects on immune and inflammatory responses, muscle sparing, and wound healing after surgery.
Methods: Two hundred patients are being randomized in a 1:1 fashion to one of two arms after nutrition screening for eligibility. Subjects are stratified by diversion type (neobladder vs. ileal conduit) and whether the patient had neoadjuvant chemotherapy (any vs. none) to balance the intervention assignment according to important prognostic factors. Nutrition drinks are given three times a day for 5 days before and 5 days after surgery. The primary endpoint is 30-day overall complication rate. Two hundred patients gives 80% power to detect an absolute reduction of 23% in the 30-day overall complication rate (from 65% down to 42%). Secondary endpoints will assess infections, muscle mass, readmissions, quality of life, recurrence, disease-free survival (DFS), overall survival (OS), immune response, cytokines, amino acids, and fatty acids. The trial is testing a high yield, low-risk, low-cost strategy to improve the outcome of patients with bladder cancer who undergo cystectomy.
Summary: This presentation will discuss the boots on the ground logistics of running a nutrition intervention across the nation and the important lessons learned related to nutrition screening for eligibility and executing a perioperative nutrition intervention in this population.
Funding: National Institutes of Health (NIH) grant awards UG1CA189974 and R37CA218118. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
About Dr. Hamilton-Reeves
Dr. Jill Hamilton-Reeves is a Professor at the University of Kansas Medical Center. Dr. Hamilton-Reeves works with urologists and medical oncologists to foster the discovery of better diet and exercise approaches to benefit patients with cancer. Her nationally-funded research program is focused on nutrition interventions in bladder cancer and prostate cancer. Dr. Hamilton-Reeves received her Ph.D. in nutrition from University of Minnesota in 2006. She is an American Cancer Society Research Scholar. Her academic career is devoted to improving patient outcomes from cancer treatment with diet and physical activity. Her work is supported by the American Cancer Society and the National Cancer Institute.
Dr. Hamilton-Reeves did not disclose any conflicts of interest for this workshop.